S&T

Due to a variety of factors — including processing conditions, amorphous content in samples, and the presence of polymorphs of specific compounds — batch-to-batch variability in active substances can pose significant challenges across all industries.

Even when chemically identical, such variability can lead to physicochemical instability and phase transitions, both of which must be avoided at every stage of manufacturing.

Understanding the causes of this variability first requires a technique capable of sensitively detecting differences between batches.

Using our innovative instruments and advanced analytical techniques, these differences can be detected at an extremely precise level.

Processing Variations

The manufacturing route of a product has a significant impact on its final physical properties, affecting surface area, amorphous content, and heterogeneity.

These changes translate into variations in moisture sorption and surface energy, which can substantially alter formulation behavior.

Using our instruments, Dynamic Vapor Sorption (DVS) technology enables highly sensitive measurement of moisture sorption characteristics, allowing for clear differentiation between batches based on changes in particle size.

In addition, iGC-SEA instruments can precisely measure product surface area, helping to establish the most suitable processing route for achieving the desired final product characteristics.

iGC-SEA Case Study 614: Effect of Processing Route on the Physical Properties of Amorphous Indomethacin.

[Request a copy] iGC-SEA Application Note 207: Characterization of Drug Polymorphs by Inverse Gas Chromatography. [Request a copy]

Pharmaceuticals

During batch-based pharmaceutical manufacturing, all deviations that could lead to changes in amorphous content, surface area, or even drug dissolution rate must be rigorously prevented.

iGC-SEA is a highly sensitive tool capable of precisely measuring subtle differences in BET surface area and surface energy profiles between different batches of the same drug.

The application note below presents a case study using iGC-SEA to analyze the differences in solubility observed when the same amorphous drug is subjected to different pre-treatment processes.

iGC-SEA Case Study 601: Identification of Batch-to-Batch Variations in the Dissolution Rate of a Pharmaceutical Drug. [Request a copy]

Polymorphs

One common cause of batch-to-batch variability is the presence of two or more polymorphs. While chemically identical, these polymorphs exhibit differences in physical properties.

Because such differences can affect the efficacy of the final product, precisely measuring and understanding the distinctions between polymorphs is essential.

Using our technology, the impact of subtle differences in amorphous content on overall material behavior can be identified — including changes in glass transition temperature.

The application note below presents a case study in which the high-sensitivity measurement capabilities of iGC-SEA were used to identify clear differences between two polymorphic drugs, and to track how one of these polymorphs is maintained following milling and exposure to high-humidity environments.

iGC-SEA Application Note 207: Characterisation of Drug Polymorphs by Inverse Gas Chromatography. [Request a copy]

Due to a variety of factors — including processing conditions, amorphous content in samples, and the presence of polymorphs of specific compounds — batch-to-batch variability in active substances can pose significant challenges across all industries. Even when chemically identical, such variability can lead to physicochemical instability and phase transitions, both of which must be avoided at every stage of manufacturing.

Understanding the causes of this variability first requires a technique capable of sensitively detecting differences between batches. Using our innovative instruments and advanced analytical techniques, these differences can be detected at an extremely precise level.

Processing Variations

The manufacturing route of a product has a significant impact on its final physical properties, affecting surface area, amorphous content, and heterogeneity. These changes translate into variations in moisture sorption and surface energy, which can substantially alter formulation behavior.

Using our instruments, Dynamic Vapor Sorption (DVS) technology enables highly sensitive measurement of moisture sorption characteristics, allowing for clear differentiation between batches based on changes in particle size. In addition, iGC-SEA instruments can precisely measure product surface area, helping to establish the most suitable processing route for achieving the desired final product characteristics.

iGC-SEA Case Study 614: Effect of Processing Route on the Physical Properties of Amorphous Indomethacin. [Request a copy] iGC-SEA Application Note 207: Characterization of Drug Polymorphs by Inverse Gas Chromatography. [Request a copy]

Pharmaceuticals

During batch-based pharmaceutical manufacturing, all deviations that could lead to changes in amorphous content, surface area, or even drug dissolution rate must be rigorously prevented. iGC-SEA is a highly sensitive tool capable of precisely measuring subtle differences in BET surface area and surface energy profiles between different batches of the same drug.

The application note below presents a case study using iGC-SEA to analyze the differences in solubility observed when the same amorphous drug is subjected to different pre-treatment processes.

iGC-SEA Case Study 601: Identification of Batch-to-Batch Variations in the Dissolution Rate of a Pharmaceutical Drug. [Request a copy]

Polymorphs

One common cause of batch-to-batch variability is the presence of two or more polymorphs. While chemically identical, these polymorphs exhibit differences in physical properties. Because such differences can affect the efficacy of the final product, precisely measuring and understanding the distinctions between polymorphs is essential.

Using our technology, the impact of subtle differences in amorphous content on overall material behavior can be identified — including changes in glass transition temperature. The application note below presents a case study in which the high-sensitivity measurement capabilities of iGC-SEA were used to identify clear differences between two polymorphic drugs, and to track how one of these polymorphs is maintained following milling and exposure to high-humidity environments.

iGC-SEA Application Note 207: Characterisation of Drug Polymorphs by Inverse Gas Chromatography. [Request a copy]